Managing Research Finances: Successful Strategies for Viability and Compliance

1
Managing Research FinancesSuccessful Strategies
for Viability and Compliance

• July 29, 2006
• M. Paul Wade, Jr., MS
• Financial and Contracts Compliance Officer

2
Elements of Clinical Research
Clinical
Regulatory
Operations
3
Operational Structure

• Directors/Principal Investigators
• Sub-Committee
• Budgeting
• Contracts
• Financial Set Up
• Clinical Delivery (Logistical)
• Billing
• Financial Tracking

4
Directors/P. I./Sub-Committee

• Study Procurement (P.I.s, Directors,
  Coordinators)
• Study Evaluation (Directors, P.I., Coordinator)
• Determine Patient Population
• Clinical Merits
• Multi-Disciplinary Sub-Committee Approval

5
Budgeting/Contracts/Financial Set-up

• Standard of Care (SOC) vs. Non-Standard of Care
  (nSOC) Review
• Budget Development
• Contract Review
• Budget/Contract Negotiations
• Financial Set-Up

6
Budgeting/Contracts/Financial Set-up

• Standard of Care (SOC) vs. Non-Standard of Care
  (nSOC) Review
• Billing Compliance
• P.I./Study Coordinator Review

• In September of 2000 CMS issued a final coverage
  decision for Medicare to cover the routine health
  care costs of beneficiaries in clinical trials.
• The rules for billing standard of care to
  research patients is subject to varying
  interpretations. Therefore, BE CONSISTENT IN
  YOUR PROCESSES.

7
Budgeting/Contracts/Financial Set-up

• Budget Development
• Start-Up Costs (Administrative, Regulatory, etc.)
• IRB Fees
• Pharmacy Fees
• Coordinator Time/Overhead
• Device/Drug
• CPT codes for nSOC Labs, Tests and Procedures
• Screen Failures
• Unpaid Insurance Claims
• File Storage

8
Budgeting/Contracts/Financial Set-up

• Contract Review Important Elements
• Determine the parties
• Study Description/Protocol Exhibit/FDA approval
• Terms are well defined
• Performed in strict compliance with the protocol
• Anti-kickback, Anti-fraud language
• Indemnification/Insurance/Adverse Outcomes
• HIPAA
• Mutual Confidentiality
• Data Ownership
• Publications
• Inventions/Intellectual Property
• Termination

9
Budgeting/Contracts/Financial Set-up

• Budget/Contract Negotiations
• Allow enough time
• Know your limits
• Amicably negotiate

10
Budgeting/Contracts/Financial Set-up

• Financial Set-Up
• Medicare Approval
• Drug/Device Procurement
• Process for getting IDE on the Bill
• Set up Accounts

11
Clinical Delivery/Billing/Financial Tracking

• Clinical Delivery (Logistical)
• Billing
• Financial Tracking

12
Clinical Delivery/Billing/Financial Tracking

• Clinical Delivery (Logistical)
• Communication (Depts., CRCs, Regulatory and
  Finance)
• Drug/Device
• Communicating Enrollments
• Inter-office/facility communication
  (collaboration with outside entities)

13
Clinical Delivery/Billing/Financial Tracking

• Billing
• Account Holds
• Investigational Device Exemptions (IDEs)
• IDE Number in Item 23 on CMS-1500
• QA Modifier for all services related to the IDE
• Account Review
• Coding Routine Costs
• QV modifier on line item level (outpatient only)
• Diagnosis code V70.7 reported as the secondary or
  subsequent diagnosis
• Trial Name, Sponsor and Protocol number if
  applicable and requested
• Periodic Audit for Billing Compliance

14
Clinical Delivery/Billing/Financial Tracking

• Financial Tracking
• Database
• Payment Modeling
• Incoming Checks
• Outgoing Checks
• Invoicing Process
• Operational Analysis
• Revenue
• Expenses
• Statistics

15
QUESTIONS?
M. Paul Wade, Jr. 95 Collier Road, Suite
5005 Atlanta, Georgia 30309 (404)
605-2372 paul.wade_at_piedmont.org